Search Results

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D or roflufocon E-with the following properties: Refractive Index, Light Transmission (clear), Light Transmission (tinted), Wetting Angle (Dynamic contact receding angle), Specific Gravity, Oxygen Permeability (Dk) ISO/FATT Method, Visitint lenses contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D. The lenses are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Secondary Curves, Peripheral Curves, Multifocal Power.

The provided document is a 510(k) Premarket Notification for the iSee Daily Wear Orthokeratology Contact Lenses. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

Instead, the document focuses on demonstrating substantial equivalence to an already marketed predicate device (OPTIMUM GP OK Daily Wear Contact Lens). The basis for this equivalence is a comparison of technological characteristics, materials, production methods, and intended use.

Here's a breakdown of why this document doesn't provide the requested AI/ML device study information:

• Non-Clinical and Clinical Studies (Section VII): This section explicitly states:
  • "The non-clinical performance data to establish the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to the predicate devices."
  • "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E have been addressed in previous applications."

This means that C&E GP Specialists, Inc. did not conduct new independent studies for this 510(k) submission. They are relying on existing data for the materials and the predicate device to establish safety and effectiveness.

Therefore, I cannot provide the requested information from this document for an AI/ML device since it is for a contact lens and references prior data rather than presenting a new study.

Ask a specific question about this device

The HEXA100 (hexafocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia.

The HEXA100 (hexafocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The HEXA100 (hexafocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The HEXA100 (hexafocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The HEXA100 (hexafocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The HEXA100 (hexafocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.

In the HEXA100 (hexafocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for HEXA100 averages > 98% in the UVB range of 280nm - 315nm and >84% in the UVA range of 316 - 380nm.

The HEXA100 (hexafocon A) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17.

The HEXA100 (hexafocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.

The HEXA100 (hexafocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "10 Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible 10 Hydra-PEG, the underlying material (hexafocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness.

The HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

The HEXA100 (hexafocon A) Daily Wear Contact Lens is available in the Spherical. Toric. Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:
• Chord Diameter: 7.0mm to 22.0mm

• Center Thickness: Varies
• Base Curve: 5.0mm to 8.0mm
• Spherical Powers: -20.00 Diopters to +20.00 Diopters
• Toric Powers: up to -10.00 Diopters
• Add Powers: up to +4.00 Diopters

The HEXA100 (hexafocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters:
● Chord Diameter: 6.5 to 11.5 mm
● Center Thickness: 0.10 to 0.70 mm

• Base Curve (BC): 6.5 to 11.0 mm
  ● Secondary Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
  ● Peripheral Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
• Spherical Powers: -10.00 to +3.00 D

Acceptance Criteria and Device Performance for HEXA100 (hexafocon A) Daily Wear Contact Lens

This submission establishes substantial equivalence for the HEXA100 (hexafocon A) Daily Wear Contact Lens by comparing its performance to predicate devices. The acceptance criteria are essentially demonstrated equivalence to these established devices through physical, chemical, and biological testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device demonstrates performance equivalent or superior to predicate devices across various physical and chemical properties and biocompatibility. The acceptance criteria for the HEXA100 (hexafocon A) Daily Wear Contact Lens are implicitly set by the performance characteristics of its predicate devices and internal validation for safety and stability.

Ask a specific question about this device